AccessGUDID - DEVICE: Stableline Tubing Organizer (Sterile) (00814321020209)

GUDID

Device Identifier (DI) Information

Brand Name: Stableline Tubing Organizer (Sterile)
Version or Model: 5000S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Movair, Inc.

Primary DI Number: 00814321020209
Issuing Agency: GS1
Commercial Distribution End Date: December 14, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 788403103 *Terms of Use

Device Description: The Stableline is designed to stabilize and contain one to six tubing lines of varying sizes which connect cardiopulmonary bypass equipment for delivery or return of fluids to and from the surgical field. The product attaches to the surgical drapes and prevents the tubing lines from slipping, while keeping them out of the way of appropriate procedures. This component is a disposable, single use item.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62137	Medical/surgical interventional tube/cable securement clip, single-use	A device intended to hold, position, and organize medical/surgical interventional tubing (e.g., arterial/venous lines, gas lines, drainage catheters, irrigation tubing) or cables to an equipment, drape or gown; it is not intended to affix the tubing to the patient directly. It is typically designed as a clip or a block with clips. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRI	Accessory Equipment, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 99920646-7b5d-4619-9ed3-f4498f10b859
Public Version Date: February 24, 2025
Public Version Number: 9
DI Record Publish Date: July 15, 2016